Gao Zhong, Zhang Weiqiang, Chen Xinyuan
Shanghai Testing&Inspection Institute for Medical Devices, Shanghai, 201318.
Zhongguo Yi Liao Qi Xie Za Zhi. 2020 Apr 8;44(4):302-306. doi: 10.3969/j.issn.1671-7104.2020.04.004.
Concerning on the safety risks caused by electromagnetic interference of patients implanted with high-risk active implantable medical devices in the environment of domestic MUs, this study evaluates and focuses on the requirements of electromagnetic compatibility in domestic and international standards for rail transit vehicles, the main mechanism of risks caused by EMI, the actual measurement of environmental data in MUs and the working performance of various active implantables in the compartment. The test results shows that all kinds of active implantable medical device samples works normally in the CRH2A EMU in China, and there is still a large margin between the measured radiation emission in MU and the limit required by the standards.
针对在国内地铁环境中植入高风险有源植入式医疗器械的患者因电磁干扰而产生的安全风险，本研究评估并聚焦于轨道交通车辆国内外标准中的电磁兼容性要求、电磁干扰导致风险的主要机制、地铁环境数据的实际测量以及车厢内各种有源植入设备的工作性能。测试结果表明，各类有源植入式医疗器械样本在中国CRH2A动车组中均能正常工作，地铁内测得的辐射发射与标准要求的限值之间仍有较大余量。
